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Nucleoside Metabolic Inhibitor

Lemzoparlimab for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study Summary

This trial is being done to find out how safe and well tolerated lemzoparlimab is in combination with azacitidine and venetoclax in adult participants with AML or MDS.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DLTs of Lemzoparlimab (TJ011133) When Co-administered With Azacitidine With or Without Venetoclax in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndrome (MDS)
DLTs of Lemzoparlimab (TJ011133) as a Monotherapy in Japanese Participants with R/R MDS
Dose Limiting Toxicities (DLTs) of Lemzoparlimab (TJ011133) When Co-administered With Venetoclax and Azacitidine in Participants With Treatment-Naïve Acute Myeloid Leukemia (AML) Ineligible for Standard Induction Therapy
+1 more
Secondary outcome measures
Best Overall Response of CR or Complete Remission With Partial Hematologic Recovery (CRh) for AML
Muscular Dystrophy
Best Overall Response of CR or PR or mCR, for MDS
+13 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: Lemzoparlimab Monotherapy in MDS (Japan Only Escalation)Experimental Treatment1 Intervention
Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Group II: Lemzoparlimab Monotherapy in AML (Japan Only Escalation)Experimental Treatment1 Intervention
Lemzoparlimab (TJ011133) administered in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
Group III: Lemzoparlimab + Azacitidine in MDS (Escalation)Experimental Treatment2 Interventions
Lemzoparlimab (TJ011133) co-administered with azacitidine in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Group IV: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Expansion)Experimental Treatment3 Interventions
Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Group V: Lemzoparlimab + Azacitidine + Venetoclax in MDS (Escalation)Experimental Treatment3 Interventions
Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve higher-risk myelodysplastic syndrome (MDS).
Group VI: Lemzoparlimab + Azacitidine + Venetoclax in AML (Expansion)Experimental Treatment3 Interventions
Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in expansion cohort in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
Group VII: Lemzoparlimab + Azacitidine + Venetoclax in AML (Escalation)Experimental Treatment3 Interventions
Lemzoparlimab (TJ011133) co-administered with azacitidine and venetoclax in escalated doses in participants with treatment-naïve acute myeloid leukemia (AML) who are ineligible for standard induction therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,350 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,069 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ambitions does this experiment have as its goal?

"The primary goal of this clinical trial, which will be evaluated over a 30-day period after initial exposure to the drug, is determining Dose Limiting Toxicities (DLTs) when administering Lemzoparlimab as Monotherapy in Japanese Participants with Relapsed/Refractory Acute Myeloid Leukemia. Secondary objectives include assessing Best Overall Response of CR or PR for MDS per modified IWG 2006 criteria; Event-Free Survival (EFS) for AML; and Platelet Transfusion Independence (TI) for MDS patients who were transfusion dependent at baseline."

Answered by AI

Are enrollment slots for this clinical investigation still available?

"According to clinicaltrials.gov, the trial posted on June 25th 2021 is no longer actively seeking patients. However, there are currently 3143 different trials that are recruiting volunteers at this time."

Answered by AI

What is the maximum enrollment capacity of this clinical trial?

"This experiment is no longer seeking participants. Initially posted on June 25th 2021 and last updated October 19th 2022, this trial has ended its recruitment period. There are presently 2803 trials actively taking part in the study of Acute Myeloid Leukemia, and 340 for Lemzoparlimab."

Answered by AI

What further investigations have been performed regarding Lemzoparlimab?

"Lemzoparlimab was first evaluated in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. Presently, there are 208 completed studies and 340 ongoing clinical trials; a broad majority of these experiments take place in Cleveland, Ohio."

Answered by AI

Are there ample locations within the U.S. conducting this research initiative?

"This trial is being hosted at a variety of medical centres, including the Cleveland Clinic Main Campus/ ID# 228216 in Cleveland, University of Alabama at Birmingham - Main /ID# 227071 in Birmingham and University of California, Los Angeles /ID# 227752 in LA. In total there are 16 different sites recruiting patients for this clinical study."

Answered by AI

Has the FDA sanctioned Lemzoparlimab for clinical use?

"Little evidence is currently available for Lemzoparlimab's safety and efficacy, so it was assigned a score of 1."

Answered by AI

What medical conditions is Lemzoparlimab commonly prescribed for?

"Lemzoparlimab is most commonly used for induction chemotherapy. It's also beneficial in treating a range of diseases including refractory anemias, leukemia, myelocytic and acute multilineage dysplasia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome
2021. "Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04912063.
~10 spots leftby Apr 2025
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